Investigation of the Applicability of a Home Peritoneal Dialysis (CAPD= Continuous Ambulatory Peritonealis Dialysis) Application System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 主要终点
- The average number of visits that can be omitted
研究概览
简要总结
This clinical trial is an open-label, prospective, single-arm, single center study.
In this study is planned to involve 12 patients, who need continuous ambulatory peritonealis dialysis (CAPD). Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.
详细描述
After enrollment, the patient is educated about the using of telemedicine system and then the standard CAPD will be continued in their home treatment supplemented with a telemedicine system.
There is a monthly follow-up visit in the CAPD therapy. Before each control visit a telemedicine doctor, for whom are available telemedicine data, decides whether a control visit is necessary. After that line the patient will be subjected to a personal check - up visit by another specialist, for whom the result of the telemedicine visit is unknown. At the end of the control visit, the doctor declares whether it could have been triggered the examination with the review of telemedicine data.
In the end of the study will be summarized the average number of visits that can be omitted and will be analyzed the extent to which the two medical opinions and the necessity of the visit matched.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Signed Informed consent form;
- •Patients treated with CAPD;
- •The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.
排除标准
- •The consent was withdrawn by the volunteers at any time after the information and the signed informed consent form;
- •Poor general condition;
- •Any disease which, in the opinion of the investigator, endangers the health of the volunteer and / or contraindicates the conduct of the study.
结局指标
主要结局
The average number of visits that can be omitted
时间窗: 13 months
In the end of the study will be summarized the average number of visits that can be omitted, and will be analyzed the extent to which the two medical opinions and the necessity of the visit matched.
次要结局
未报告次要终点